Prospective evaluation of a new biflanged metal stent for the treatment of pancreatic fluid collections (with videos)

Accepted Manuscript Prospective evaluation of a new biflanged metal stent for the treatment of pancreatic fluid collections (with videos) Shuntaro Mukai, MD, Takayoshi Tsuchiya, MD, Takao Itoi, MD, FASGE, Shujiro Tsuji, MD, Reina Tanaka, MD, Ryosuke Tonozuka, MD, Yuichi Nagakawa, MD, Kazuhiko Kasuya, MD, Masaaki Shimatani, MD, Atsushi Sofuni, MD PII:

S0016-5107(16)30806-9

DOI:

10.1016/j.gie.2016.11.025

Reference:

YMGE 10334

To appear in:

Gastrointestinal Endoscopy

Received Date: 10 September 2016 Accepted Date: 14 November 2016

Please cite this article as: Mukai S, Tsuchiya T, Itoi T, Tsuji S, Tanaka R, Tonozuka R, Nagakawa Y, Kasuya K, Shimatani M, Sofuni A, Prospective evaluation of a new biflanged metal stent for the treatment of pancreatic fluid collections (with videos), Gastrointestinal Endoscopy (2016), doi: 10.1016/ j.gie.2016.11.025. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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Prospective evaluation of a new biflanged metal stent for the treatment of

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pancreatic fluid collections (with videos)

Shuntaro Mukai, MD, [1] Takayoshi Tsuchiya, MD, [1] Takao Itoi, MD, FASGE, [1]

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Shujiro Tsuji, MD, [1] Reina Tanaka, MD, [1] Ryosuke Tonozuka, MD, [1] Yuichi

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Nagakawa, MD, [2] Kazuhiko Kasuya, MD, [2] Masaaki Shimatani, MD, [3] Atsushi

Sofuni, MD, [1]

Japan

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1. Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo,

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2. Third Department of Surgery, Tokyo Medical University, Tokyo, Japan

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3. Third Department of Internal Medicine, Kansai Medical University, Osaka Japan

Corresponding author: Takao Itoi, MD, PhD, FASGE

Department of Gastroenterology and Hepatology, Tokyo Medical University

6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan

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Tel.: +81-3-3342-6111, Fax: +81-3-5381-6654

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E-mail: [email protected]

Abstract

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Background and Aims: EUS-guided transluminal drainage (EUS-TD) and sequential

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direct endoscopic necrosectomy (DEN) for pancreatic fluid collections (PFCs) using a

dedicated biflanged metal stent (BFMS) has been reported as a useful alternative to

using plastic stents or a conventional metal stent. However, current dedicated BFMSs

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have limitations. Recently, a new BFMS with solidly constructed biflanges and various

stent lengths matched to the PFC condition has been developed. Herein, we

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prospectively evaluated this new BFMS for the treatment of PFCs.

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Methods: From July 2015 to July 2016, EUS-TD using the new BFMS was performed

in 12 patients for PFCs (4 patients with pancreatic pseudocysts; 8 patients with

walled-off necrosis). When clinical resolution could not be achieved, DEN was

performed the following day.

Results: The stent was deployed successfully with a median procedure time of 16 min

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(range, 11-24 min) and with no procedure-related adverse events in all the patients

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(12/12, 100%). DEN via the stent was achieved in all the patients in whom they were

attempted (4/4,100%). Spontaneous stent migration or stent dislocation during DEN

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was not observed in any of the patients. Two WON patients died from spontaneous

pseudoaneurysm rupture and multiple organ failure. The PFCs in the other 10 patients

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completely resolved, and later the stent was removed with no difficulty in 9 patients

after a median time of 48 days (range, 30-180 days).

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Introduction

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Conclusions: The new BFMS is technically feasible and safe for the treatment of PFCs.

EUS-guided transluminal drainage (EUS-TD) and sequential direct endoscopic

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necrosectomy (DEN) for pancreatic fluid collections (PFCs) using a dedicated biflanged

metal stent (BFMS) has been reported as a useful alternative to using 1 or more plastic

stents or a conventional self-expandable biliary metal stent [1-7]. Current dedicated

BFMSs are divided into lumen-apposing metal stent (LAMS) and flared metal stent

(FMS) [8]. The LAMS has limitations in the case of a longer length between the gastric

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wall and the cyst wall because the stent length between biflanges is 1 cm. In contrast,

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the FMS has limitations in terms of a weak lumen-apposing force, leading to stent

migration because of the flared flanges. Recently, a new BFMS with solidly constructed

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biflanges and various stent lengths matched to the PFC condition has been developed.

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Herein, we prospectively evaluated this new BFMS for the treatment of PFCs.

Methods

The new BFMS (HANARO stent, MI Tech, Seoul, Korea) is a fully covered metal stent

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designed for EUS-TD, with a 14-mm-diameter lumen and a 20- or 30-mm-long body

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[Figure 1]. This stent is made of a self-expanding nitinol wire and is fully covered with

a silicon membrane to minimize leakage. Both the proximal and distal anchor flanges

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are designed to hold tissue layers tight and prevent stent migration. The diameter of a

flange is 24 mm. The large lumen diameter yields effective drainage, and the short body

length and the high stability enable the easy insertion of a standard upper endoscope

into the cyst for DEN. The delivery sheath is 10.2F and the delivery system is almost

identical to that of a conventional biliary metal stent.

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Our eligibility criteria for EUS-TD using the new BFMS in a pilot observational

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study were as follows: (1) the size of the pancreatic pseudocyst (PPC) or walled-off

necrosis (WON) is >30 mm, and (2) the distance between the GI tract and the cavity

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measured under EUS is <20 mm. EUS-TD using the new BFMS was performed in 12

consecutive patients who conformed to our eligibility criteria for PFCs (ie, 4 patients

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with PPCs; 8 patients with WON) [9] between July 2015 and July 2016 at Tokyo

Medical University Hospital. The clinical results were assessed prospectively.

This study was approved by our institutional review board and written informed

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consent was obtained from all the patients. This study was registered with the

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University Hospital Medical Information Network Clinical Trials Registry (Number

UMIN000021347). Data were collected in accordance with the provisions of the

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Declaration of Helsinki.

All procedures were performed using a conventional curved linear array

echoendoscope (GF-UCT240 or GF-UCT260; Olympus Medical Systems, Tokyo,

Japan). A 19-gauge fine-needle aspiration needle was used to puncture the PFC under

EUS-guidance. A 0.025-inch guidewire was inserted into the cyst to form several loops.

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Then, the tract was dilated using a 6F electrocautery dilator and a 4- to 6-mm dilating

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balloon. Finally, a stent was deployed under ultrasound, fluoroscopic, and endoscopic

guidance [Figure 2]. The placement of a 5F or 6F nasocystic catheter for irrigation was

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left to the operator’s discretion. Clinical resolution was defined as the disappearance of

symptoms, improvement in inflammation, and the shrinkage of the PFC cavity on CT.

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When clinical resolution could not be achieved within a few days (usually 3-7 days)

after EUS-TD, DEN was performed. A standard upper endoscope was directly advanced

insufflation.

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Results

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via the stent. Necrotic tissue was removed using a snare forceps during CO2

The patients and treatment results for PFCs are shown in Table 1. The stent was

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deployed successfully with a median procedure time of 16 min (range, 11-24 min) and

with no procedure-related adverse events in all the patients. Insertion of a standard

upper endoscope through the stent and DEN were achieved in all the patients in whom

they were attempted. Spontaneous stent migration or stent dislocation during the DEN

procedures was not observed in any of the patients. Two WON patients died from

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spontaneous

pseudoaneurysm

rupture

occurring

between

the

endoscopic

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necrosectomy sessions and from multiple organ failure although hemostasis was

achieved by coil embolization. The PFCs completely resolved in the other 10 patients,

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and later the stent was removed with no difficulty in 9 patients after a median time of 48

days (range, 30-180 days) except in 1 patient who had malignant pancreatic cancer with

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a poor prognosis. PFC recurrence or stent-related late adverse event was not observed

for a median follow-up time of 186 days (range, 43-396).

Discussion

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We demonstrated that EUS-TD using a new BFMS is an effective treatment approach

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for PFCs with high technical and clinical success rates. There were no procedure-related

adverse events with the deployment or removal of the new stent. Several investigators

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have reported that a dedicated BFMS is a useful device for PFC drainage under EUS

guidance in a pilot observational study because it may provide a better drainage owing

to its large bore and a better access route for additional procedures such as DEN than

traditional plastic stent placement [10-12]. Moreover, the use of a BFMS reduces the

procedure time and technical complexity because of its ease of placement. The major

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limitation of BFMSs is the cost, making its routine use controversial. However, this may

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be overcome by less need for a repeat intervention in complicated cases. Our previous

study showed no significant difference in the total procedure cost between a plastic stent

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and a BFMS in the treatment of complicated WON cases in which DEN was needed

[13].

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The previously reported BFMSs are divided into 2 types: LAMS (AXIOS stent

and SPAXUS stent) and FMS (Niti-S; Nagi stent). FMS migration may be inevitable

because of its weak lumen-apposing function. This was shown in a multicenter national

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study conducted in Australia to evaluate FMS (Nagi stent) for EUS-TD which included

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54 cases of which 4 cases (7.4%) had stent migration during DEN and 6 cases (11.1%)

had spontaneous stent migration [14]. On the other hand, LAMS has a lower stent

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migration rate (1.1%-5%) than FMS (11.1%-19%) [6-8, 15, 16]. These data indicate that

the stability of LAMSs appears to be better than that of FMSs. The advantage of FMSs

is that the stent length between the 2 flanges is longer than that of LAMSs (20 or 30 mm

vs 10 mm); thus, the FMS is deployed safely in cases located at a long distance from the

GI tract. Moreover, the delivery system is almost identical to that of a conventional

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biliary metal stent, making it simple to use [7, 17].

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The new BFMS in this study (HANARO stent) has both advantages of the

LAMS and the FMS, the so-called “hybrid BFMS”. In our clinical experience (data not

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recorded), the radial force of the HANARO stent is comparable with that of existing

BFMSs. The lumen-apposing force of the HANARO stent may be weak compared with

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that of the AXIOS stent because the length between the 2 flanges of the HANARO stent

is longer than that of the AXIOS stent (20 or 30 mm vs 10 mm). On the other hand, the

AXIOS stent is not suitable in case of a longer distance (>20 mm) between the stomach

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and the cavity. The HANARO stent may have a similar or better lumen-apposing force

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than the SPAXUS stent because it has powerful flanges compared with the SPAXUS

stent despite having the same stent length (20 mm). The lumen-apposing force of the

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HANARO stent is better than that of the Nagi stent, which has only flared flanges. On

the other hand, the stability of the HANARO stent is equivalent to that of the AXIOS

stent because the anchor flanges of the HANARO stent are designed to hold tissue

layers tightly similarly to the AXIOS stent, preventing migration. Actually, stent

migration occurring spontaneously or during DEN was not observed in the present study.

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Because the stent body length is 20 or 30 mm and the delivery system is simple and

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similar to that of FMS, the stent adapts to various locations of the PFCs.

In 2 patients, severe bleeding in the WON cavity between DEN sessions

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occurred owing to the spontaneous rupture of the pseudoaneurysm. As the

pseudoaneurysm location was distinct from the stent, its occurrence was possibly a

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result of inflammation and not in relation with the stent. Although the clinical outcome

of WON has been improved by the development of DEN or a dedicated BFMS, several

adverse events may be inevitable during the endoscopic treatment course [18, 19]. In

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previous multicenter studies that included a large number of cases, the clinical success

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rate of EUS-TD and DEN using BFMS for WON has been reported to be approximately

80% to 90% [16,20]. The clinical success rate of 83% in the present study was within

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the clinical success range in these previous reports.

The limitations of this study include the absence of a control group and the small

case series being a prospective pilot study at a single institution. In addition, long-term

results including recurrence and late adverse events could not be evaluated. Furthermore,

all drainage procedures were performed via the transgastric route in the present study.

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Thus, the efficacy of the new BFMS for drainage via the transduodenal route could not

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be evaluated at this time.

In conclusion, the new BFMS is technically feasible and safe for the treatment

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of PFCs. Further studies using randomized-controlled, well-designed, adequately

required to validate its efficacy.

Acknowledgement

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powered studies comparing the new BFMS with previous BFMSs (LAMS or FMS) are

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We thank Dr. Edward Barroga, Associate Professor and Senior Medical Editor

from the Department of International Medical Communications of Tokyo Medical

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References

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Gastroenterol

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pii:

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walled-off

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S1542-3565(16)30196-3.

Figure legends

Figure 1. The new fully covered biflanged metal stent (HANARO stent, MI Tech, Seoul,

Korea)

Figure 2. Transgastric EUS-guided drainage using the new biflanged metal stent

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a. The distal flange was deployed under EUS and fluoroscopic guidance.

Figure 3.

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b. After the stent placement, the necrotic fluid was drained through the stent.

Endoscopic necrosectomy through the new biflanged metal stent

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a. A standard upper endoscope was directly advanced via the stent.

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b. Necrotic tissue was removed using a snare forceps.

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Patient

Age

no.

(y)/sex

Disease

Maximum Stent size of

size

PFC

(mm)

Access route Technical Procedure Full expansion success

time

after

(min)

placement Yes

Additional Adverse events

Clinical

Stent

procedure

success

removal (days)

(mm) 96

30

Transgastric Yes

17

2

36/M

Sterile PPC

54

30

Transgastric Yes

16

3

68/M

Infected PPC

73

30

Transgastric Yes

16

4

77/F

Infected PPC

115

30

Transgastric Yes

5

80/M

Sterile WON

95

30

6

44/M

Infected WON

73

20

7

79/M

Infected WON

106

30

8

75/M

Infected WON

129

30

No

Yes

180

No

No

Yes

42

Yes

No

No

Yes

46

17

Yes

No

No

Yes

Remained

Transgastric Yes

11

Yes

No

No

Yes

37

Transgastric Yes

11

Yes

No

No

Yes

48

Transgastric Yes

15

Yes

DEN

No

Yes

58

Transgastric Yes

15

Yes

DEN

Rupture of

Death

N/A

Death

N/A

Yes

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No

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Sterile PPC

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65/M

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1

pseudoaneurysm

9

50/M

Infected WON

200

30

Transgastric Yes

25

Yes

DEN

Rupture of pseudoaneurysm

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64/M

Infected WON

128

30

Transgastric Yes

18

No

No

No

Yes

63

DEN

No

Yes

60

Additional No

Yes

40

Additional balloon 11

67/M

Infected WON

147

30

Transgastric Yes

15

Yes

12

81/F

Infected WON

105

20

Transgastric Yes

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dilation

Yes

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Table 1. Patients and treatment data for pancreatic fluid collections

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drainage

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PFC, pancreatic fluid collection; PPC, pancreatic pseudocyst; WON, walled-off necrosis; DEN, direct endoscopic necrosectomy; N/A, not available

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Author contributions study design, data analysis, and script preparation: Shuntaro Mukai, Takao Itoi; endoscopic procedures: Takayoshi Tsuchiya , Shujiro Tsuji, Reina Tanaka, Ryosuke Tonozuka, Atsushi Sofuni ; data collection: Shuntaro Mukai ; manuscript supervisors: Yuichi Nagakawa, Takao Itoi, Kazuhiro Kasuya, Masaaki Shimatani. All authors have read and approved the submitted version of the paper.

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Acronyms

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EUS-TD, EUS-guided transluminal drainage; DEN, direct endoscopic necrosectomy; PFC, pancreatic fluid collection; BFMS, biflanged metal stent; LAMS, lumen-apposing metal stent; FMS, flared metal stent; PPC, pancreatic pseudocyst; WON, walled-off

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necrosis

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IRB and Patient Consent Declaration This study was approved by our institutional review board (Tokyo Medical University No. 3141) and written informed consent was obtained from all the patients. This study was registered with the University Hospital Medical Information Network Clinical Trials Registry (Number UMIN000021347). Data was collected in accordance with the provisions of the Declaration of Helsinki.